The Effect of Artistic Activities on Anxiety, Spiritual Well-Being, Hope, and Vital Signs in Patients Undergoing Abdominal Surgery: A Randomized Controlled Trial

June 2, 2026 updated by: Eda Ayten Kankaya, Dokuz Eylul University
The surgical process can cause high levels of anxiety and stress in patients, and abdominal surgery is particularly anxiety-provoking due to the risk of severe pain and complications. Artistic activities can be an effective complementary method for reducing anxiety and improving mental well-being and hope levels in individuals. Studies have shown that activities such as music therapy and visual arts have positive effects on pain, anxiety, and vital signs in surgical patients. This randomized controlled trial aims to evaluate the effects of artistic activities on anxiety, spiritual well-being, hope, and vital signs in patients undergoing abdominal surgery. The research will be conducted on patients undergoing abdominal surgery at the Department of General Surgery at Dokuz Eylül University. The data collection tools used will be the "Patient Assessment Form," "Vital Signs Form," "Visual Analog Anxiety Scale," "Spiritual Well-Being Scale," and "State Hope Scale." The intervention group will participate in mandala coloring as an artistic activity, while the control group will perform breathing exercises. Data analysis will be conducted using the SPSS 29.0 software package. Descriptive and analytical statistics will be used in the data analysis. The results of the study will determine the effect of artistic activities performed on abdominal surgery patients in the preoperative period on anxiety, spiritual well-being, hope, and vital signs. Based on the effectiveness of preoperative artistic activities in clinical use, a decision will be made as to whether they are useful in preparing patients for surgery in the preoperative period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be 18 years of age or older

    • Be scheduled to undergo elective abdominal surgery (stomach, esophagus, colorectal, hepatobiliary)
    • Be conscious and able to communicate
    • Be willing to participate in the study

Exclusion Criteria:

  • Patients requiring emergency abdominal surgery

    • Patients with chronic psychiatric disorders
    • Patients with severe cognitive impairment
    • Patients with severe hearing or vision loss
    • Patients requiring intensive care
    • Patients with degenerative brain disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Art group
mandala group
Behavioral: Art activities
In the study, pre-tests and post-tests were administered to patients in the experimental and control groups by the first researcher in the patients' rooms. The pre-test data for the study will be collected using the "Patient Diagnosis Form," "Vital Signs Form," "Visual Analog Anxiety Scale," "Spiritual Well-Being Scale," and "State Hope Scale" through face-to-face interviews lasting an average of 10 minutes. After the data is collected, the experimental group will participate in art activities from the body and mind therapy group, while the control group will perform breathing exercises. Final test data will be collected 10 minutes after the activities are completed.
Active Comparator: Control group
deep breathing exercises
Behavioral: breathing exercises
the control group will perform breathing exercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
anxiety
Time Frame: Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.
Anxiety levels will be measured using the Visual Analog Anxiety Scale (VAAS). The scale ranges from 0 to 10, where 0 indicates no anxiety and 10 indicates the highest possible anxiety. Higher scores represent worse anxiety. The baseline (pre-test) measurement will be obtained during a face-to-face interview prior to the intervention.
Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.
Spiritual Well-Being
Time Frame: Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.
Spiritual well-being will be assessed using the Spiritual Well-Being Scale.It was developed by Daaleman and Frey (2004), and its Turkish validity and reliability study was conducted by Serbest and Şahin (2022). The scale consists of 12 items and two subscales (self-efficacy and life plan). Participants' responses are rated on a 5-point Likert-type response scale ranging from 1 = "Strongly agree" to 5 = "Strongly disagree." The total score of the scale ranges from 12 to 60. The baseline (pre-test) measurement will be obtained during a face-to-face interview prior to the intervention.
Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.
State Hope
Time Frame: Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.
Hope levels will be assessed using the State Hope Scale. The scale consists of six items. Responses were collected using an 8-point Likert scale (1= Strongly disagree, 4= Somewhat disagree, 8= Strongly agree).
Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vital signs
Time Frame: Baseline (pre-test), before the intervention-assessed once immediately prior to the intervention.
Vital signs will be assessed using the Patient Vital Signs Form, which includes blood pressure, pulse, respiratory rate, temperature, and pain level. Measurements will be obtained following standard clinical procedures during the baseline (pre-test) assessment prior to the intervention. Values will be interpreted according to established physiological reference ranges, and higher pain scores represent worse symptoms.
Baseline (pre-test), before the intervention-assessed once immediately prior to the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nazife Gamze Özer Özlü, Phd, Dokuz Eylul university Nursing Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9711-GOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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